AUROCIN PLUS EAR CLEANSER- salicylic acid, phytosphingosine hydrochloride solution

Aurocin by

Drug Labeling and Warnings

Aurocin by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Aurocin™ Plus Ear Cleanser

Ear Cleansing Solution + PS for Dogs and Cats

ACTIVE INGREDIENTS: Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%.

INACTIVE INGREDIENTS: Water, SDA 40B 190 Proof, Propylene Glycol, Disodium Oleamido MIPA Sulfosuccinate, Glycerin, Nonoxynol-12, Benzoic Acid, Benzyl Alcohol, Lactic Acid, Tetrasodium EDTA, Sodium Dioctyl Sulfosuccinate, Aloe Barbadensis Leaf Juice, Fragrance.

PROPERTIES: Aurocin™ Plus Ear Cleansing Solution is specifically formulated to deodorize and gently clean, dry and acidify the ear canal. This
provides an optimal environment to help maintain healthy ears. Aurocin™ Plus also contains phytosphingosine, a pro-ceramide to help support a
healthy skin barrier.

INDICATIONS & USAGE

INDICATION: For use on dogs and cats only. For cleansing and/or drying the ear canal.

DIRECTIONS FOR USE: Moisten a cotton ball with solution and place in ear canal.  Gently massage base of ear for 60 seconds, remove cotton ball and allow pet to shake its head. Wipe away visible debris and excess solution.

WARNINGS AND PRECAUTIONS

CAUTIONS: For external use only; avoid contact with the eyes.  If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use in the case of a suspected ruptured eardrum.

WARNING: Keep out of the reach of children.

STORAGE AND HANDLING

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Distributed by: MWI

Boise, Idaho 83705

www.VetOne.net

Questions?

1-800-999-0297

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

NDC 13985-727-04

VETONE®

Aurocin™ Plus

Ear Cleanser

Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%

Ear Cleansing

Solution + PS

for Dogs and Cats

For veterinary use only

Phytosphingosine

Net Content: 4 FL. OZ. (118 mL)

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

NDC 13985-727-08

VETONE®

Aurocin™ Plus

Ear Cleanser

Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%

Ear Cleansing Solution + PS

for Dogs and Cats

For veterinary use only

Phytosphingosine

Net Content: 8 FL. OZ. (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

NDC 13985-727-16

VETONE®

Aurocin™ Plus

Ear Cleanser

Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%

Ear Cleansing Solution + PS

for Dogs and Cats

For veterinary use only

Phytosphingosine

Net Content: 16 FL. OZ. (473 mL)

INGREDIENTS AND APPEARANCE

AUROCIN  PLUS EAR CLEANSER
salicylic acid, phytosphingosine hydrochloride solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-727
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.5 mg  in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	PHYTOSPHINGOSINE HYDROCHLORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)
NONOXYNOL-12 (UNII: 6NR43D77O6)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LACTIC ACID (UNII: 33X04XA5AT)
EDETATE SODIUM (UNII: MP1J8420LU)
DI-N-OCTYL SODIUM SULFOSUCCINATE (UNII: 4YLY5570Y0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-727-04	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 13985-727-08	237 mL in 1 BOTTLE, PLASTIC
3	NDC: 13985-727-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2017

Labeler - MWI/VetOne (019926120)

Registrant - Ceva Sante Animale (261126049)